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Guidance on Blood Donor Suitability in Ebola Outbreaks

12/03/2015

Federal Register Notice: FDA is making available a draft document entitled Recommendations for Assessment of Blood Donor Suitabili...

Guidance on Veterinary Feed Directive Common Format

12/01/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Veterinary Feed Directive Common Format Qu...

FDA Sends Info on Tropical Disease Vouchers to OMB

11/18/2015

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Tropical Disease Priority...

Comments Sought on Safety Reporting, Electronic Submissions

11/18/2015

Federal Register Notice: FDA is seeking public comments on a proposed collection of information on the use of the FDA Electronic S...

Guidance on Biosimilar Sponsor Formal Meetings

11/18/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Formal Meetings Between the FDA and Biosimilar B...

FDA Posts Approved PMAs

11/18/2015

Federal Register Notice: FDA is publishing a list of PMAs that have been approved and is informing the public of the availability ...

Guidance on Labeling for Drugs Containing Acetaminophen

11/17/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Organ-Specific Warnings: Internal Analgesic, Ant...

Alexion Pharma Receives Voucher for Strensiq

11/17/2015

Federal Register Notice: FDA is issuing a priority review voucher to the sponsor of a rare pediatric disease product application, ...

Comments Sought on IVD Device Studies Guidance

10/23/2015

Federal Register Notice: FDA is seeking public comments on guidance on informed consent for in vitro diagnostic device studies usi...

OMB OKs Info on Device Recall

10/23/2015

Federal Register Notice: FDA’s collection of information entitled “Medical Device Recall Authority” has been app...